MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFNT60
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following an intraocular lens (iol) implant procedure, refractive deviations after cataract surgery were observed in both eyes.Axis shift of 5-10 degrees in the post op left eye although the target refraction was -0.20 in the company device, +0.50 hyperopia and -1.50 post-astigmatism for the left eye op +1 and -.2.25 astigmatism.There are two medical device reports associated with this event.This report is associated with the left eye.Additional information was requested and received.

• Brand Name: ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13621064
• Report Number: 1119421-2022-00364
• Device Sequence Number: 12216669
• Product Code: MFK
• UDI-Device Identifier: 00380652391634
• UDI-Public: 00380652391634
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: TFNT60
• Device Catalogue Number: TFNT60.205
• Device Lot Number: 12705905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CENTURION, OZIL; DISCOVISC; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR
• Patient Age: 60 YR
• Patient Sex: Male